The government, via the National Institute for Health Research (NIHR) of the United Kingdom (UK), announced a £20 million infusion into six research studies focusing on new COVID-19 vaccines in a quest to establish the UK as a major scientific presence in leading the medical response to the novel coronavirus now sweeping the globe. These new research endeavors follow up on other infusions of capital into UK research targeting the novel coronavirus.
This government investment, targeting 2 COVID-19-focused vaccine clinical trials, was announced by Alok Sharma, UK Business Secretary on 23 March 2020. This important capital will inject life into not only vaccine trials but also support the development of vaccine manufacturing at a scale of one-million doses. The other projects center on the repurposing of existing drugs and the development of antibodies that could target the virus as well as risk-based methods to identify the most at risk individuals. The funding supports the vitally important British national health system (NHS) and associated research efforts. Of course, the hope is that these investments will accelerate all of the efforts.
The projects include the following:
- Repurposing existing therapies. Patients being treated by the NHS for coronavirus are taking part in a new clinical trial to test existing therapies developed for other conditions such as HIV. These therapies might help improve patients’ recovery
- Developing antibodies that target coronavirus. Researchers are aiming to develop a new coronavirus therapy by developing antibodies that target the disease – doing so will help treat a range of coronavirus infections and help people’s immune systems recognize the disease and destroy it
- Testing approved drugs. Researchers will test around 1,000 approved drugs on cells in laboratory conditions to determine if they might be able to treat the disease
- Answering urgent questions relating to coronavirus. Scientists will collect samples and data from patients diagnosed with coronavirus in the UK to answer important questions including which peoples have a higher risk of severe illness, the best way to diagnose the disease, how their immune systems are coping, and closely monitoring the effects of drugs being used. The data could help control the outbreak and improve treatments for patients
UK Science Advisor Patrick Vallance reported, “The UK is home to incredible scientists and researchers who are all at the forefront of their field, and all united in their aim; protecting the people’s lives from coronavirus.”
Follow on to other Funding
This most recent government announcement follows £30 million of new government funding for the National institute for Health Research to enable further rapid research into COVID-19, and an additional £10 million to increase Public Health England’s ability to test people and monitor the virus as was recently announced in the budget.
Moreover, this most recent £20 million was in addition to £20 million allocated to the Health Secretary in February 2020 for the Coalition for Epidemic Preparedness Innovations (CEPI). Moreover, in January 2020 the Medical Research Council (part of the UKRI) directly funded £0.5 million each to two centers:
The MRC Centre for Global Infectious Disease Analysis at Imperial College London—contributing world-leading outbreak modeling and transmission dynamics and liaising with WHO.
The MRC-University of Glasgow Centre for Virus Research, which has investigated the genetics and origins of the virus.
What follows is a more granular description of the research projects for TrialSite News readers.
Dr Kenneth Baillie, University of Edinburgh, Professor Peter Openshaw, Imperial College London, and Professor Calum Semple University of Liverpool – £4.9 million
The project involves collecting samples and data from COVID-19 patients in the UK to answer many urgent questions about the virus and provide real-time information, which could help to control the outbreak and improve treatment for patients. Their questions include:
- who in the population is at higher risk of severe illness
- what is the best way to diagnose the disease
- what is happening in their immune systems to help or harm them
- closely monitoring the effects of drugs used in patients with COVID-19
- how long are people infectious for and from which bodily fluids
- whether people with COVID-19 are infected with other viruses (e.g. flu) at the same time
They will recruit at least the first 1,300 UK patients who agree to take part over the next year and aim to start communicating their initial results in months. The team’s capacity builds on planning over the past 8 years as part of the International Severe Acute Respiratory Infection Consortium, and it includes co-investigators from 6 UK universities and Public Health England.
Professor Sarah Gilbert, University of Oxford – £2.2 million
The team are already developing a new vaccine against the COVID-19, as they initiated vaccine development as soon as the genetic sequence of the novel coronavirus was released. This funding will support preclinical testing of the new vaccine, vaccine manufacturing and then clinical trials in people. The first stage of human testing will be in adults aged 18-50, later expanding the trial to adults over 50 years and school age children. The vaccine is made from a harmless virus, an adenovirus, which has been altered to produce the surface spike protein of the coronavirus after vaccination, to prime the immune system to recognize and attack the coronavirus. If the vaccine is shown to be safe and effective in these earlier trials, vaccine manufacturing will be scaled up for larger studies. The vaccine utilizes the same technique as a vaccine the team previously developed for the closely related MERS coronavirus, which showed promise in animal and early-stage human testing. This earlier research was funded by the UK Vaccines Network (a DHSC and UKRI initiative) in 2018.
Professor Peter Horby, University of Oxford – £2.1 million
A clinical trial has started in the UK to test if existing or new drugs can help patients hospitalized with confirmed COVID-19. The drugs will be tested to see if they are safe and effective when added to the usual standard of care. The trial will have an ‘adaptive’ design, meaning it can test new therapies as they become available. The first 2 therapies to be tested will be HIV drugs: lopinavir-ritonavir and low-dose corticosteroids. The trial is called Randomized Evaluation of COVID-19 Therapy (RECOVERY). The research team’s ambitious aim is to have data available to inform patient treatment within 3 months.
Professor Xiao-Ning Xu, Chelsea and Westminster Hospital, Imperial College London – £0.6 million
This research aims to develop antibodies that target the novel coronavirus with the aim of developing a new therapy for COVID-19. Antibodies are molecules produced by the body’s immune system that can specifically recognize and bind to structures, such as those on the surface of a virus, to block the virus entry and instruct the immune system to destroy it. They have already identified some antibodies that might bind to proteins from the COVID-19 coronavirus. In collaboration with China, the scientists will use these in this project to develop a potential antibody therapy, with the aim of getting the therapy to the stage where it is ready to enter clinical trials to determine if it can treat a range of coronavirus infections including the COVID-19 coronavirus.
Dr Sandy Douglas, University of Oxford – £0.4 million
The team are aiming to develop manufacturing processes for producing harmless virus, adenovirus vaccines at a million-dose scale, so that – if clinical trials are successful – a vaccine could be made available to high-risk groups as quickly as possible. They are working with Professor Sarah Gilbert’s team, who are developing promising novel coronavirus vaccines by modifying harmless adenoviruses.
Professor Ultan Power and Professor Ken Mills, Queens University Belfast – £0.3 million
This project will test a library of approximately 1,000 drugs on cells in the laboratory to determine if any can reduce the toxic effects of novel coronavirus infection. The drugs are already approved for use in humans. They will be tested on airway epithelial cells grown in the lab and infected with novel coronavirus to determine if the drugs can reduce virus infection or replication and virus-induced inflammatory responses. This could identify promising drugs for further testing and clinical trials in 12 months.